FDA Under Fire for Meningitis Outbreak

As the death toll continues to rise in the nation’s fungal meningitis outbreak , the Food and Drug Administration is coming under fire for its handling of the public health crisis. The consumer group Public Citizen says the outbreak was “completely avoidable” and accused the FDA of ducking responsibility.

In a letter to U.S. Health & Human Services Secretary Kathleen Sebelius, Public Citizen called for an independent investigation of the FDA by the agency’s Inspector General.  Federal health officials say as many as 14,000 pain patients received epidural injections of a contaminated steroid made by the New England Compounding Center (NECC).

“The FDA clearly is incapable of conducting an objective evaluation of its own policy, oversight, and enforcement decisions, which clearly contributed to this ongoing preventable tragedy,” wrote Michael Carome, MD, deputy director of Public Citizen’s Health Research Group.

Carome cited a recent comment by FDA Deputy Commissioner Deborah Autor, who told reporters it was “really unfortunate that it sometimes takes a tragedy” to bring about change. Carome called her statement an attempt to shift blame.

“Public Citizen is deeply troubled by this attempt by one of the most senior figures within the FDA to deflect criticism for the agency’s failures with respect to the fungal meningitis outbreak by claiming that the agency lacked the legal authority to take earlier action against NECC. Such statements appear to be a deliberate attempt to mislead the public,” Carome wrote.

“The claims by agency officials that the FDA lacks authority to properly regulate compounding pharmacies is contradicted by a long history of remarkably consistent statements and enforcement actions asserting the agency’s legal authority over such pharmacies.”

The FDA regulates drug manufacturers, but conflicting court rulings have led it to largely defer to states when it comes to overseeing compounding pharmacies, which make drugs for patients who need custom formulations of prescription drugs.

“While no one relishes being viewed as culpable for a public health crisis, the FDA’s attempt to dodge responsibility in this matter is outrageous,” wrote Carome. “To protect the public interest, however, it also is imperative that all parties contributing to this crisis be identified and held accountable. Among such parties is the FDA, which has failed to use its existing, long-established legal authority to effectively regulate the large-scale production and distribution of drugs by companies acting under the guise of compounding pharmacies.”

In 2006, the FDA issued a warning letter to NECC expressing its concerns about marketing anesthetic creams and potential  contamination associated with repackaging a cancer drug to treat an eye disease.

While the FDA has not yet commented on Public Health’s charges, Commissioner Margaret Hamburg applauded the agency’s efforts at containing the meningitis outbreak. In a blog on the FDA website she wrote:

“The FDA has been working closely with the CDC and public health officials in Massachusetts and other states to investigate the scope and cause of the outbreak. In fact, both agencies have been working hand-in-hand with our colleagues in every state affected by this outbreak.”

Meanwhile, the Centers for Disease Control and Prevention (CDC) now confirms a 24th fatality, with Indiana reporting a third death due to fungal meningitis. Nine more infections were reported in Michigan, New Jersey and Virginia, bringing the total number of infections to 317.

Authored by: Richard Lenti